NCT00240981

TOM: Testosterone in Older Men With Sarcopenia

Testosterone Replacement for Older Men With Sarcopenia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

Detailed description

The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID). Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained.

Conditions

• Sarcopenia
• Hypogonadism
• Muscular Diseases

Interventions

Type	Name	Description
DRUG	Topical testosterone gel 1% (active formulation)	Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
DRUG	Topical gel (placebo formulation)	Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2005-10-18
• Last updated: 2017-02-23
• Results posted: 2017-02-23

Locations

2 sites across 1 country: United States